QA Specialist (Biotech) needs 3 years of experience in the biotech / pharmaceutical industry within research and development or commercial organizations.
QA Specialist (Biotech) requires :
o Pharma Biotech industry
o Veeva
o cGMP manufacturing environment
o FDA
o Kneat
o Slinshot
o SAP
o Blue mountain RAM
o Knowledge of manufacturing batch record review and / or analytical analyses for the biotech / pharmaceutical
o Degree in Chemistry biological or other
QA Specialist (Biotech) duties :
o Responsible for performing inspection and disposition of raw materials and components by :
o Supporting incoming material release activities within the ERP system ensuring compliance with applicable regulations and internal procedures.
o Get Certificates of Analysis (CoA) Certificates of Compliance (CoC) and other required documentation from vendors in alignment with the Master Specification
o Conduct thorough reviews of logbooks and Work Orders across Manufacturing Engineering Quality and Warehouse departments to ensure entries are complete accurate and compliant with company policies and procedures.
o Responsible for providing QA review / approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.
Key Skills
Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration
Employment Type : Full Time
Experience : years
Vacancy : 1
Hourly Salary Salary : 37 - 38
Qa Specialist • Morrisville, North Carolina, USA